Omzara Tablet 150 mg (Momelotinib Hydrochloride Hydrate)

Adult dose

This medicine is administered orally at a dose of 200mg once daily. It may be taken with or without food. If a dose of this medicine is missed, take the scheduled dose the following day. Before starting treatment with this medicine, periodically during treatment, and when clinically indicated, perform a complete blood count and liver function tests. 1. Dose adjustment Dose adjustment should be considered for hematologic and nonhematologic toxicity (Table 1). Discontinue this medicine if the 100mg once-daily dose is not tolerated. Table 1. Dose adjustment for adverse reactions Hematologic toxicity Thrombocytopenia Baseline platelet count ≥100 × 109/L, platelet count 20 × 109/L~<50 × 109/L: Reduce the daily dose by 50mg from the last administered dose. Baseline platelet count ≥100 × 109/L, platelet count <20 × 109/L: Temporarily interrupt treatment until the platelet count recovers to 50 × 109/L. Resume treatment at a daily dose reduced by 50mg from the last administered dose.b Baseline platelet count ≥50 × 109/L ~ <100 × 109/L, platelet count <20 × 109/L: Temporarily interrupt treatment until the platelet count recovers to 50 × 109/L. Resume treatment at a daily dose reduced by 50mg from the last administered dose.b Baseline platelet count <50 × 109/L, platelet count <20 × 109/L: Temporarily interrupt treatment until the platelet count recovers to baseline. Resume treatment at a daily dose reduced by 50mg from the last administered dose.b Neutropenia ANC <0.5 × 109/L: Temporarily interrupt treatment until ANC ≥0.75 × 109/L. Resume treatment at a daily dose reduced by 50mg from the last administered dose.b Nonhematologic toxicity Hepatotoxicity (unless there is another clear cause) ALT and/or AST >5 ×ULN (if abnormal at baseline, >5 × baseline) and/or total bilirubin >2 × ULN (if abnormal at baseline, >2 × baseline): Temporarily interrupt treatment until ALT and AST recover to ≤2 ×ULN or baseline values and total bilirubin recovers to ≤1.5 × ULN or the baseline value. Resume treatment at a daily dose reduced by 50mg from the last administered dose.b If an increase in ALT or AST to >5 ×ULN recurs, permanently discontinue this medicine. Other nonhematologic toxicity Grade 3 or higher nonhematologic toxicityC Grade 2 or higher bleedingC Temporarily interrupt treatment until the toxicity recovers to Grade 1 or lower or baseline values. Resume treatment at a daily dose reduced by 50mg from the last administered dose.b ANC = absolute neutrophil count; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal a If clinically appropriate, restart treatment or gradually increase the dose up to a maximum of 200mg once daily. b If the last administered dose was 100mg, treatment may be restarted at 100mg. C Adverse reaction grades are based on the Common Terminology Criteria for Adverse Events (CTCAE). 2. Patients with renal impairment No dose adjustment is necessary in patients with renal impairment (see Precautions for Use ‘12.2. Pharmacokinetic Properties 5) Special Populations’). 3. Patients with hepatic impairment No dose adjustment is necessary in patients with mild or moderate hepatic impairment. The recommended starting dose of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) is 150mg once daily (see Precautions for Use ‘12.2. Pharmacokinetic Properties 5) Special Populations’).

This medication should not be administered to patients who are allergic to this drug or any of its components. Additionally, because this drug contains lactose, it should not be used in patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. When taking this medication, side effects such as diarrhea, thrombocytopenia, nausea, headache, dizziness, fatigue, weakness, abdominal pain, and cough may commonly occur. Especially, thrombocytopenia can manifest as a serious side effect, so platelet counts should be monitored regularly through blood tests. The risk of infection may also increase, so if symptoms of infection, such as fever, cough, diarrhea, vomiting, or pain during urination occur, it is essential to inform medical staff immediately. Patients with chronic hepatitis B must carefully examine and manage liver function and viral status before and during the use of this medication. Occasionally, this drug may increase the risk of cardiovascular issues or thrombosis, so elderly patients or those with cardiovascular risk factors should discuss with a doctor before use. Dizziness or blurred vision can occur while taking this medication, so caution is required when driving or operating machinery. Additionally, this medication may interact with certain drugs, so if taking other medications, it is essential to inform healthcare professionals. Women of childbearing age should avoid becoming pregnant while taking this drug, and the effectiveness of hormonal contraceptives may be reduced, so additional contraceptive methods should be used. This medication can harm the fetus, so if pregnant or planning to become pregnant, consulting a doctor is imperative. It is recommended that breastfeeding women discontinue breastfeeding while taking this medication. Safety and efficacy have not been established in children or adolescents under 18 years of age, so it should not be used in this population. This medication should be kept out of reach of children and should not be transferred to other containers.

• Diarrhea
• Thrombocytopenia
• Nausea
• Headache
• Dizziness
• Fatigue
• Asthenia
• Abdominal pain
• Cough
• Infection

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is important to store it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

Brown triangular film-coated tablets

Package unit

30 tablets/bottle